HRQoL was quantified through the Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) questionnaire which was composed of two parts: FACT-General (FACT-G) which featured general questions, and FACT-Lym Lymphoma-specific Subscale (FACT-Lym LYMS). The reported results were grouped into three main summary measures: FACT-Lym trial outcome index (FACT-Lym TOI), FACT-G score, and FACT-Lym Total Score (FACT-Lym TOT).

Key Highlights:

396 pts were recruited and randomized

Treatment:

B group = B at 120mg/m2/day D1+D2 of each 28D cycle, max six cycles

G-B group = B at 90mg/m2/day D1+D2 of each 28D cycle: G at 1,000mg D1, D8, D15 of the first 28D cycle, then D1 of cycles 2–6, max six cycles

Pts without CR, PR, or SD by end of cycle 6 received 1,000mg G maintenance every two months, up to two years

HRQoL questionnaire given at D1 of cycles 1, 3 and 5, at end of cycle 6, annually until PD

Pts undergoing G-maintenance were additionally given HRQoL every two months for two years or until PD

More patients reported meaningful improvement in G-B group than B group reported through FACT-Lym TOI, FACT-Lym LYMS, and FACT-Lym TOT scores

In conclusion, the authors state that this study shows that the improved PFS seen in the G-B arm of the GADOLIN study did not result in poorer HRQoL due to treatment-related toxicities and adverse events, however the study was limited by the decay in successful complete of the FACT-Lym questionnaires.

We present health-related quality of life (HRQoL) data from GADOLIN, comparing bendamustine (B) alone or combined with obinutuzumab (G-B) in rituximab-refractory indolent non-Hodgkin lymphoma patients. The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) questionnaire was administered on day 1 of cycles 1, 3, and 5 during treatment, at end of induction (EOI), bi-monthly for 2 years during maintenance/follow-up, and annually during extended follow-up until progression/death. Time to first ≥6-point worsening from baseline in the FACT-Lym trial outcome index (TOI) was estimated. Minimally important differences at individual subscale and total score level were used to define the proportion of patients reporting improvement on the FACT-Lym lymphoma-specific subscale (≥3 points), FACT-Lym TOI (≥6 points), and FACT-Lym total score (≥7 points). Overall, 396 patients were randomized. Analysis was conducted when 175 Independent Review Committee-assessed progression-free survival (PFS) events were observed. Questionnaire completion rates were generally balanced between arms at baseline, EOI, and final follow-up. Median time to ≥6-point worsening from baseline on the FACT-Lym TOI was 8.0 months in the G-B arm and 4.6 months in the B arm (HR 0.74; 95% CI 0.56–0.98). More G-B patients reported meaningful improvements on the FACT-Lym questionnaire subscales. Results were similar when follicular lymphoma patients were analyzed separately. The delayed time to worsening and greater proportion of patients reporting meaningful improvement in HRQoL in the G-B arm suggest that benefit in PFS is not at the expense of an increase in treatment-related toxicity that could lead to reduced HRQoL.